NCT04670263

Evaluating the Efficacy of Dry Eye (DE) Disease Treatment Using Novel Tear Film Imager (TFI)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Adom Advanced Optical Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid. AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.

Detailed description

80 subjects will be enrolled , 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye. Healthy and Dry eye groups will be age- matched. Over a period of 4 weeks, the subjects diagnosed with dry eye will be treated and as follows: 1. Hylo-comod artificial tears (0.1 % sodium hyaluronate) 8 times a day for 4 weeks 2. Coll STERODEX (Dexamethasone sodium phosphate 0.1% eye drops) 3 times a day for 2 weeks Healthy subjects will not receive any treatment. Both groups will be examined at baseline and 4 weeks after baseline measurement. Treatment results will be measured by both traditional methods and by Tear Film Imager.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Tear Film Imager	Tear Film Imager recording

Timeline

• Start date: 2020-03-08
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2020-12-17
• Last updated: 2022-07-12

Locations

1 site across 1 country: Israel